GROUP LEAD – CLINICAL DATA MANAGEMENT – 4501 URA

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View: 143

Update day: 24-04-2024

Location: Lausanne Vaud VD

Category: Other

Industry: Research Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Our client is a multinational company based in French speaking part of Switzerland performing Clinical Research in areas such as nutritionals by prototyping capabilities to accelerate the translation of science into innovation. They offer dynamic, inclusive, and international working environment with many opportunities across different companies, functions, and regions. We are currently looking for a Group Lead – Data Management to work within their clinical development unit for a permanent position.

As a Group lead in Data management, you are a person with a robust understanding of the ongoing changes and transformations in the clinical research arena and more specifically a leader in clinical data management to further enable this journey. Beyond the traditional clinical data management aspect, the expectations are to fully embrace the power of digital towards decentralized or hybrid clinical trials and the implementation of risk-based data management strategy. You will need to have a pragmatic view on how emerging study designs, decentralized clinical trials, regulations and technology innovations are dramatically reshaping the discipline of clinical data management.

Main Responsibilities
  • Act as a change management agent of the CDM transformation, lead initiatives required to modernize operations
  • Lead a team of data managers ,optimize the team competence mix to support the company innovative spirit
  • Lead the strategy on the data management IT tool
  • Accountable for the annual forecast and budget for CDM activity
  • Define, implement and manage vendor oversight strategies tailored for the insourcing/outsourcing scope and model
  • Lead the scouting, assessment, and implementation of new digital tools
  • Enabling risk-based CDM strategies for studies
Qualifications And Experience
  • Master Degree or equivalent experience
  • 7+ years’ experience within Clinical Data Management
  • Experience with CDMS/EDC (including Medidata) and SAS
  • Knowledge of CDISC standards including SDTM preferred
  • Understanding of the following concepts: eSources data flows and processes, Decentralized Clinical Trials, Complex protocol designs such as “Basket”, “Umbrella”, and “Adaptive”
  • Up to date on regulations regarding clinical data collection and on clinical data standards such as: GCP (Good Clinical Practice), GCDMP (Good Clinical Data Management Practices), data privacy, and new regulations like GDPR (General Data Protection Regulation)
  • Attention to detail & organisational skills
  • Passion & enthusiasm
  • Problem solving skills with a desire to improve current processes
  • Ability to ‘think outside of the box’
  • Excellent communication skills, both oral and written in English
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Deadline: 08-06-2024

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